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Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women

Comparison of the effect of oral tablet of Metronidazole with vaginal cream of Jaft concurrent with oral tablet of Metronidazole on results of Bacterial Vaginosis (BV) management in childbearing age women

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2016071428929N1
Enrollment
168
Registered
2016-09-07
Start date
2016-09-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Vaginosis. Diseases of the Genitourinary system

Interventions

Intervention 1: The first intervention group, Oral tablet of Metronidazole 250 mg
2 tablet
every 12 h, is given for 7 days. Intervention 2: The second intervention group vaginal cream of Jaft (one Applicator every night) is given coccurent with oral tablet of Metronidazole 250mg, 2 table
Treatment - Drugs
The first intervention group, Oral tablet of Metronidazole 250 mg
every 12 h, is given for 7 days.
The second intervention group vaginal cream of Jaft (one Applicator every night) is given coccurent with oral tablet of Metronidazole 250mg, 2 tablets every 12 h.

Sponsors

Vice Chancellor for Research, Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Willingness to cooperate in the study; Married women of reproductive age (18 - 45); Symptoms of BV on clinical examination and confirmed by Amsel criteria (having three of four criteria) and confirmation by Gram stain and Nugent score should be 7-10; Lack of recent use of oral and topical medications such as Alkaloids, Anti-parasitic, Immunosuppressive drugs and other drugs during the past two weeks, according the patient report; No sexual intercourse during the past 24 hours; Lack of abnormal uterine bleeding (AUB); Lack of frequent bacterial infections which are resistant to treatment; Not to be pregnant and lactation; Lack of vaginal douche in the past 48 hours; Lack of specific diseases such as Liver disease, diseases of the Central Nervous System, Diabetes, Immune deficiency, according to patient report; Non-use of broad-spectrum Antibiotics, Anti-prostaglandins, Hormone therapy and Immunosuppressive, Anticoagulant and drug abuse in recent months; No history of hypersensitivity to Metronidazole; The patient should have only BV not other types of Vaginitis. Exclusion Criteria: Possible sensitivity to the drug (vaginal cream of Jaft), which is not seen so far; Lack of application of vaginal cream (Jaft or Placebo) and oral Metronidazole or discontinuing treatment; Taking any medication affecting the vaginal cream including Alkaloid drugs; Taking any medication affecting the symptoms of BV including broad-spectrum Antibiotic to treat other infections in the patient; Unwillingness of patients to continue or to cooperate; People who are considered sick on the patient's clinical symptoms but their test results does not endorse BV.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Vaginal Discharge. Timepoint: Before and after the treatment of a week. Method of measurement: Through Smears of Vaginal discharges and Gram stained smears.

Secondary

MeasureTime frame
To reduce infectious factors such as bacteria and clinical symptoms. Timepoint: After a week of treatment. Method of measurement: Through the smears of vaginal discharges and gram stained slides.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Moshfeghy

School of Nursing and Midwifery, Shiraz University of Medical Sciences

zmoshfeghy1385@yahoo.com+98 917 313 7561

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026